We live in a global marketplace, and because of this, medical device manufacturers have a lot of power supply companies to choose from. When shopping around for a USA power supply for your medical device, you may wonder why working with a domestic manufacturer matters. We’ll cover the benefits of working with an American-based partner, how it simplifies regulatory approval, and why it gives you a competitive edge in the medical industry.
The U.S. Medical Device Market
The U.S. medical device market is the largest in the world, making up 43.5% of the total global medical technology landscape. Business is booming for medical devices, and the FDA has made it easier than ever to gain approval in the market. The chances are good that if you are currently manufacturing and selling a medical device, you are building it and trying to get it approved right here at home.
USA Power Supply Compliance: FDA and IEC 60601-1 Standards
If you work with a U.S. manufacturer of power supplies that caters to medical devices, you won’t have to worry as much about being FDA-compliant.
For medical device manufacturers that want to sell in the United States, their equipment needs to be compliant with the latest version of IEC 60601-1. You can run into roadblocks in two ways. First, working with a power supply manufacturer that doesn’t cater to medical devices based in the U.S. might mean you have to take extra steps to ensure compliance. Harmonized standards can mean that meeting the standard in one country will qualify you in another. However, depending on the country manufacturing the power supply, they may or may not be compliant with US-based standards, or they may be behind.
RAM Technologies’ medical PSUs are compliant and certified to meet the standards set by IEC 60601-1 edition 3.2. Choosing a power supply shouldn’t mean taking a step back in getting your product to market.
Working With Outsourced Suppliers Can Be More Difficult
Working with power supply manufacturers outside the U.S. can be a cost-effective option. Still, the cost savings may only be an upfront benefit.
First, there’s the time you may have to wait to receive your power supplies. If you’re working with a country outside of the US, chances are it’ll take longer for items to arrive if they have to pass through customs. Say something isn’t quite right, and you need to make a revision – the back-and-forth time to get your power supply customized the way you need it will slow down the time it takes to get to market.
This is assuming that you can get your power supply customized at all. When you work with manufacturers that are more affordable, it’s likely that you won’t have as many options to customize your power supplies to meet your exact specifications, either. The process may be more cookie-cutter with these suppliers, leaving you with the burden to alter the PSUs yourself or work with another company to make alterations once you receive them from an international manufacturer.
One of our recent customers shared why they prefer a USA power supply over foreign alternatives, stating:
“I really appreciate that we can find somebody local. If I reach out, I get a response back. You guys have added extra wires for us, we’ve sent power supplies back and forth. It’s really nice to have people you can deal with versus an entity overseas where who knows what you’re gonna get.”
RAM Technologies offers custom power solutions that comply with all applicable regulations and meet the specifications of your project. You don’t have to back into what you’re looking for. We can get it right the first time.
U.S. Manufacturers of Power Supplies Can Be More Reliable
When it comes to medical devices, reliability matters. Medical devices must be safe, predictable, and have little to no downtime. All components a manufacturer uses also need to be available for the lifetime of the product.
Our products are designed and manufactured by American engineers who understand the demands of the medical industry. Lower-priced power supply solutions from overseas may be budget-friendly initially, but they often come with shorter warranties and unknown supply chain risks. RAM’s long-life, reliable power supplies are backed with a 3-year warranty. Our products also have a demonstrated mean time between failures (MTBF) of 500,000 hours. We can also make your supply chain more efficient with:
– Shorter lead times
– Easier communication
– Fewer logistics issues
– Reduced geopolitical risk
– Improved long-term product support
When you work with a U.S. manufacturer, you have access to faster engineering support. When design changes arise, customers shouldn’t have to wait days or weeks for answers. RAM Technologies gives customers direct access to engineering support so your questions about cable configurations, connector options, output requirements, and integrations can be resolved quickly.
You also want reliability when it comes to knowing that the power supply you need will still be on the market for the life of your product. If the power supply you use in your medical devices changes, you’ll have to select a new one and repeat the certification process.
Suppliers outside of the U.S. often can’t accommodate custom orders, either. Because manufacturing and engineering are closely integrated, RAM Technologies can support custom cable assemblies, connector configurations, and specialized output requirements without the delays often associated with overseas suppliers.
RAM guarantees that our power supplies will remain available throughout your product lifecycle. In fact, we’ve been producing the first PSUs we’ve been making since 1996.
Have Questions About Choosing the Right USA Power Supply?
Sometimes, you need questions answered quickly. We don’t just pride ourselves on having the most reliable and powerful PC medical power supplies since 1996.
We’re also happy to be able to answer questions and offer support for anyone who is looking for the right power supply for their medical device. Help is an email or phone call away. Whether you are plugging into a standard wall outlet or require specialized inputs, our wide range of products will meet your needs.
RAM Technologies’ medical power supplies are 60601-1 3.2 certified and meet 60601-1-2 EMC standards. When you’re designing your medical device and need help with your power requirements, contact us for details.
RAM Technologies’ power supplies are 60601-1 3.2 certified and meet 60601-1-2 EMC standards. When you’re designing your medical device and need help with a PSU, contact us for details.
More Resources:
What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers
Downloadable Guide to IEC 60601-1
Differences Between 3.1 and 3.2 Certification for IEC 60601-1
Understanding IEC 60601-1-2